ETCO
2
The ResQCPR™ System includes the following two components:
1. ResQPUMP
®
ACD-CPR Device
2. ResQPOD
®
ITD 16
ResQCPR System Component:
ResQPUMP ACD-CPR Device
DEVICE DESCRIPTION
The ResQPUMP ACD-CPR Device (hereafter
referred to as ResQPUMP) (Figure 1) is a
multi-use, hand-held device that includes a
suction cup for attachment to the patient’s
chest (with clothing removed), and a handle
for the rescuer to hold onto.
The ResQPUMP enables the rescuer to perform active compression-
decompression cardiopulmonary resuscitation (ACD-CPR), which differs from
standard CPR. During ACD-CPR, the chest is actively re-expanded (decompressed) after each
compression; with standard CPR, the chest re-expands passively. The ResQPUMP design allows
the operator to use the same body position and compression technique as in standard CPR.
Active chest decompression is achieved when the rescuer maintains a firm grip on the ResQPUMP,
bends at the waist and pulls his or her body weight upwards after compression. The suction cup
sticks to the chest and transfers the lifting force to the middle of the ribcage. Compression force
is transferred to the chest as in standard CPR via the device’s piston. The handle includes a force
gauge that displays the forces exerted during both chest compression and decompression (chest
wall recoil). The ResQPUMP has a battery-powered metronome integrated into the handle to guide
the rescuer in the appropriate compression/decompression rate. The metronome emits two-tone
signals of the same duration, one low and one high pitch tone. The signal (set at 80/minute)
guides the rescuer to compress and decompress at the appropriate rate and for equal amounts of
time (50% duty cycle).
If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an adequate
seal. It may be necessary to shave hair from the middle of the chest to achieve good suction.
NOTE: If suction difficulties persist, the ResQPUMP can still be used for compressions without
causing additional harm to the patient, as long as it does not distract from CPR quality.
ResQCPR System Component: ResQPOD ITD 16
Instructions For Use
All users must read and fully understand these
ResQCPR System Instructions for Use (IFUs)
before using the ResQCPR System
or any of its components. The ResQCPR™
System includes the following components:
1. ResQPUMP
®
ACD-CPR Device
2. ResQPOD
®
ITD 16
USER INFORMATION: The use of other
medical equipment or drugs in conjunction
with cardiopulmonary resuscitation (CPR) may
impact the effect of compressions/decompres-
sions. Consult the instructions for use for other
equipment or drugs to assure that they are
used appropriately in conjunction with active
compression decompression CPR (ACD-CPR)
with an impedance threshold device (ITD) -
the ResQCPR System.
REQUIRED SKILLS: The ResQCPR System
should be used only by persons with
appropriate training, such as ambulance and
rescue personnel, or other medical staff who
have already completed a conventional CPR
course (e.g. American Heart Association,
American Red Cross, or equivalent), and who
have been trained on use of the ResQCPR
System.
RX ONLY
Federal Law (USA) restricts this
device system to sale by or on
the order of a licensed medical
practitioner.
CONTRAINDICATIONS
None known.
WARNINGS
Improper use of the ResQCPR System could cause serious injury to the patient and
ineffective chest compressions/decompressions. The ResQCPR System should only
be used by personnel who have been trained in its use.
Improper positioning of the ResQPUMP suction cup may result in possible
injury to the rib cage and/or internal organs, and may also result in suboptimal
circulation during ACD-CPR.
Do not use the ResQPUMP if the patient’s chest is not large enough for the ResQPUMP
suction cup to provide adequate compressions/decompressions during use.
Moisture, gels, or other lubricating materials on the patient’s chest should be removed
before applying the ResQPUMP. Failure to do so may result in sliding
of the suction cup on the chest, ineffective chest compressions/decompressions, and
possible injury to the rib cage or internal organs.
The ResQPUMP should not be used in patients who have had a recent
sternotomy. Use of the ResQPUMP in patients with a recent sternotomy
(within the past 6 months) has not been evaluated, but this may potentially cause
serious injury.
The safety and effectiveness of CPR using the ResQCPR System have not been
assured when used to treat cardiac arrest in patients with drug/medication
overdose etiology.
If the patient has a return of spontaneous circulation (ROSC) (e.g. palpable pulse)
during the resuscitation efforts, the ResQPOD should be immediately
removed from the airway circuit and use of the ResQPUMP should be
discontinued. Failure to do so may cause shortness of breath, difficulty breathing and
potential pulmonary edema if the patient begins to breathe spontaneously.
The ResQCPR System has not been studied in the setting of in-hospital cardiac arrest;
therefore, the safety and effectiveness of the device in this setting are unknown.
Clinical outcomes when using the ResQCPR System in the setting of an in-hospital
cardiac arrest. Therefore, the safety may be different from the outcomes observed in
the clinical trials of out-of-hospital cardiac arrest.
Safety and effectiveness of the ResQCPR System in pregnant women and
children under the age of 18 have not been studied in clinical trials.
Safety and effectiveness of the ResQCPR System in the setting of traumatic
injury (wounds resulting from sudden physical injury) have not been established.
PRECAUTIONS
Figure 1: ResQPUMP ACD-CPR Device
Metronome
Force Gauge
Handle
Suction Cup
Figure 2: ResQPOD ITD 16
On/Off Switch for
Timing Assist Lights
Inspiratory
Impedance
Regulator
Timing Assist Lights
Safety Check
Valve
INSPECTION PRIOR TO USE
Carefully inspect the ResQPOD in its package
before opening. Do not use if package is
opened or damaged, or if any defects are
noted.
HOW SUPPLIED
The ResQPOD ITD 16 is non-sterile and
intended for single patient use only. Dispose
of properly when use is completed.
DEVICE DESCRIPTION
The ResQPOD ITD 16 (hereafter referred to
as ResQPOD) (Figure 2) is a non-sterile, single
patient use, disposable impedance threshold device (ITD) that limits passive air entry into
the lungs during the chest wall recoil (decompression) phase of CPR, thereby
reducing intrathoracic pressure when rescuers are not providing a breath. Lowered intrathoracic
pressure results in greater venous return (preload) which, in turn, results in greater cardiac output
on the subsequent compression. It is inserted into the airway circuit between the patient and
the ventilation source, and can be used with either a facemask or advanced airway (e.g.
endotracheal [ET] tube). The ResQPOD may be used with standard ventilation sources (e.g.
bag-valve or demand-valve resuscitators, rescuer’s mouth, automated ventilator). It does not
restrict the patient’s ability to exhale, nor the rescuer’s ability to ventilate. The ResQPOD allows
the rescuer to provide periodic positive pressure ventilation while impeding passive inspiratory
gas exchange during the chest recoil phase. The ResQPOD ITD 16 includes a safety check
valve that allows inspiration at -16 cmH
2
O. The check valve is a design safety feature in the
event that the patient begins to breathe independently while the device is in place within the
airway circuit. Timing assist lights provide guidance to the rescuer on the proper ventilation rate
for a patient with an advanced airway.
PERFORMING CPR USING THE RESQCPR SYSTEM
Before beginning CPR with the ResQCPR System
(ACD-CPR with an ITD; Figure 3), always assess
the patient according to local standards to assure
there are no signs of circulation (e.g. consciousness,
breathing, coughing, movement or pulse). Begin
performing CPR with the ResQCPR System as soon
as possible but do not delay manual chest
compressions while preparing the ResQCPR devices.
PERFORMING CPR USING THE RESQCPR
SYSTEM IN ADULTS
1. Assure that patient is pulseless and that
resuscitation is indicated.
2. Place ResQPUMP; turn on metronome and begin
performing compressions to appropriate depth
(e.g. 2” or 5 cm) depth at rate of 80/min (see
additional detailed instructions on the use of the ResQPUMP below).
3. Attach ResQPOD to facemask as soon as chest compressions begin; use a
2-handed technique to maintain a tight facemask seal and airway position
(see additional detailed instructions on the use of the ResQPOD below).
4. After 30 compressions, pause and administer two ventilations over one
second duration each until the chest rises.
5. Continue to provide a 30:2 compression to ventilation ratio until pulse returns or
advanced airway is placed. Rotate ACD-CPR duties every two minutes to avoid fatigue.
6. Once an advanced airway (e.g. ET tube, supraglottic airway) is placed:
• Conrm tube placement and secure with commercial tube restraint.
• Move the ResQPOD to the airway and turn on the timing assist lights.
• Provide asynchronous ventilations; ventilate once (over one second until chest
rises) each time light flashes (10/min).
• Perform continuous chest compressions at 80/min. Do not pause compressions
for ventilations.
• Rotate ACD-CPR duties every two minutes to avoid fatigue.
7. If the patient has a return of spontaneous circulation (ROSC) the ResQPOD should
be immediately removed from the airway circuit and use of the ResQPUMP should be
discontinued. If the patient re-arrests, resume use of the ResQCPR System immediately.
Figure 3: Use of the ResQCPR System
NOTE: Signs and symptoms of improved
cerebral blood flow (e.g. eye opening,
gagging, spontaneous breathing, limb or
body movement) have been reported in
patients without a spontaneous pulse but
who are undergoing resuscitation with the
ResQCPR System. If these are noted, check
quickly to see if a spontaneous pulse has
returned. If the patient remains in cardiac
arrest, continue resuscitation with the
ResQCPR System and contact your medical
control authority or local protocol for
guidance on managing these signs and
symptoms in an arrested patient. If a
spontaneous pulse has returned, discontinue
the ResQCPR System and support ventilations
as indicated.
THE RESQCPR TEAM
It is highly recommended that rescuers work
in teams of 3 - 4 people. This enables one
person to perform ACD-CPR, one person
to hold the facemask in place with the
ResQPOD attached, and a third person to
manage the defibrillator and observe the
patient for signs of ROSC. In this team
scenario, the person compressing the chest
can stop after 30 compressions to provide
two positive pressure breaths (<5 seconds),
before resuming chest compressions. With
more personnel, two rescuers can manage
the airway.
ENSURING HIGH QUALITY CPR WITH
THE RESQCPR SYSTEM
• Check the ResQPUMP’s force gauge at
regular intervals to ensure that the
appropriate forces needed to compress
and decompress are being delivered.
• Use the ResQPUMP’s metronome as a
guide for compressing and decompressing
at the rate of 80/min. NOTE: This rate is
slightly slower than the rate recommended
for standard CPR in order to allow sufficient
time for blood return to the chest, and to
reduce rescuer fatigue.
• Rotate ACD-CPR duties every two minutes
to avoid fatigue.
• Once the patient has an advanced airway
placed, use the ResQPOD’s timing assist
lights to guide the proper ventilation rate.
Ventilate over one second duration and do
not hyperventilate!
• Avoid unnecessary interruptions.
DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPUMP
Proper use of the ResQPUMP is shown in Figures 4 through 9.
RESQPUMP POSITIONING
The ResQPUMP’s compression point is the same as for standard
manual CPR (Figure 4). Position the suction cup in the middle of the
sternum between the nipples (mid-nipple line). Make sure that the
edge of the suction cup does not extend below the xiphoid process,
as this could result in inadequate suction and/or rib injury.
RESCUER POSITION
Kneel close to the patient’s side. For optimal position, shorter
rescuers may find it beneficial to be slightly elevated by kneeling on
padding. If the patient is in bed (with hard surface under torso), it
will be necessary to kneel next to the patient or stand on a platform
of sufficient height. Grasp the ResQPUMP’s handle with both hands,
placing the heels of the hands near the gauge with wrists slightly
bent (Figure 5).
COMPRESSIONS WITH THE RESQPUMP
Compress the chest to the recommended depth (e.g. 2” or 5 cm),
observe the force required to achieve that depth, and then use that
force target as a guide. The amount of force required will vary
according to how compliant the chest is. Compress with shoulders
directly over the sternum, with arms outstretched and elbows locked
(Figure 6). Use the large thigh muscles to compress, bending at the
waist. Compress at a rate of 80/min and use the metronome to
guide the compression rate. Start and stop the metronome by
pressing the red button on the force gauge (Figure 7). Compress the
chest on one tone and lift on the other tone.
Note: The compression rate using the ResQPUMP
(80 compressions per minute) is different than the
current AHA-recommended rate of 100-120
compressions per minute for standard CPR.
COMPRESSION FORCE
The red arrow tip indicates the force being applied (Figure 7).
The approximate amount of force required to compress the
chest two inches (5 cm) is as follows:
• 30 kg (≈ 65 lb) of force: soft/supple chest
• 30 - 40 kg (≈ 65 - 90 lb) of force: chest of medium/average
compliance (Figure 7)
• 50 kg (≈ 110 lb) of force: stiff/rigid chest
Once it has been determined how much force is required to
compress the chest to the appropriate depth, use that amount of
force as a guide for continued compressions.
DECOMPRESSIONS WITH THE RESQPUMP
To provide active decompression, use the large muscles in the thighs
to lift, bending at the waist (Figure 8).
DECOMPRESSION FORCE
Decompress (lift) the chest until the tip of the red arrow on the force
Figure 4
Figure 5
gauge registers -10 kg (≈ –20 lb) of force (Figure 9). This amount of upward
force must be exerted to fully achieve the benefits of active decompression.
Closely monitor the force gauge and suction cup seal during use. If the suction
cup dislodges, reposition it with the next compression; then, on the next
decompression, lift until just before the suction cup releases but do not exceed
-10 kg (≈ -20 lb) of lift. Use a 50% duty cycle, spending equal time compressing
and decompressing.
SUCTION CUP REMOVAL
Lift up an edge of the suction cup lip to release the vacuum under the cup.
This will free the cup from the patient’s chest.
Figure 6
Figure 7
Decompression
Compression
30
0
kg
40
15
10
50
80/min
LIFT to 10 kgs
Use enough
force to
COMPRESS
to 2” (5 cm) depth
Figure 8
Figure 9
TROUBLESHOOTING
1. If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an
adequate seal. It may be necessary to shave hair from the middle of the chest to achieve
good suction. NOTE: If suction difficulties persist, the ResQPUMP can still be used for
compressions (with the metronome disabled) without causing additional harm to the
patient, as long as it does not distract from CPR quality.
2. Rib fractures can occur with any method of CPR, even if performed correctly. If it appears
that rib fractures have occurred, check to make sure the suction cup is properly positioned
and that compression depth is appropriate. The occurrence of rib fractures is not sufficient
reason to discontinue ACD-CPR.
3. If there are questions about whether the ResQPUMP is functioning properly, consider
discontinuing its use and perform standard manual CPR instead.
DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPOD ON
A FACEMASK
1. It is important to insert the ResQPOD into the ventilation circuit as soon as
chest compressions begin. In most cases this will involve placement on a
facemask; however, never delay the initiation of chest compressions while
waiting to place the ResQPOD.
2. The ResQPOD may be used on patients with or without an oral or nasal
airway.
3. Attach the ResQPOD to the facemask. (Figure 10)
4. Obtaining and maintaining a tight facemask seal throughout
both chest compressions and ventilations is critical. To achieve
this, spread out the cushion of the mask. (Figure 11)
5. Use a two-handed technique to maintain proper airway positioning and
obtain a tight facemask seal. Place the facemask onto the patient,
covering the nose and mouth. Obtain a tight facemask seal by either:
A. Using the thumb and base of the palm (Figure 12); or
B. Forming a “C” with thumb and index finger.
6. Place the remaining fingers on the bony part of the lower jaw and lift the
lower jaw to the facemask. Do not push the facemask into the face to try
and obtain a seal.
7. Tilt the head back and continue to lift the lower jaw to the mask.
(Figure 13)
8. Attach the ventilation source to the top of the ResQPOD.
9. DO NOT turn on timing assist lights. If rescue personnel elect to
perform continuous chest compressions and ventilate asynchronously with a
facemask, then the lights may be turned on and the rescuer should provide
a positive pressure ventilation on the upstroke of ACD-CPR every time the
light flashes.
10. Administer ResQCPR using the proper compression to ventilation ratio
(e.g. 30:2) and the proper ventilation duration (e.g. one second).
11. If there is only one rescuer available to manage the airway, then the
rescuer who is performing chest compressions can reach over and
provide ventilations during the pause in chest compressions, while
the rescuer at the airway maintains a two-handed facemask seal.
(Figure 13)
12. The ResQPOD is disposable and intended for single patient use. Cross
contamination may occur if the device is used on multiple patients.
1. Insert the advanced airway and confirm tube placement. Secure the tube
with a commercial tube restraint device. The use of tape to secure the tube
is not recommended.
2. Attach the ResQPOD to the top of the airway and attach the ventilation
source to the top of the ResQPOD (Figure 14); avoid interrupting CPR to
do this.
3. Turn on the timing assist lights. To activate, slide the ON/OFF switch to
the ON position.
4. Perform ResQCPR with continuous chest compressions (no pauses for
ventilations). Ventilate asynchronously when the timing lights flash (10/min)
and over proper duration (e.g. one second) until the chest rises.
5. If an end-tidal carbon dioxide detector is used, place it in the airway circuit
between the ResQPOD and the ventilation source. (Figure 15)
6. If there is desire to administer medications via the advanced airway,
remove the ResQPOD and administer medications directly into the tube,
then re-connect ResQPOD and resume use.
ADDITIONAL INSTRUCTIONS:
1. If there is a return of spontaneous circulation (e.g. palpable pulse) and chest
compressions are no longer indicated, immediately remove the ResQPOD
from the airway circuit. Failure to do so may cause shortness of breath and
difficulty breathing. Support respirations as indicated.
2. Immediately replace the ResQPOD in the ventilation circuit if the patient
re-arrests and chest compressions are again indicated.
3. If vomit or secretions enter the ResQPOD, remove the ResQPOD from the
facemask or airway adjunct and use the ventilation source to clear the
material from the ResQPOD. Suction the patient as needed, then re-attach
the ResQPOD and resume use. Discontinue use of the
ResQPOD if it cannot be cleared or if positive pressure ventilation is
compromised in any way with the device in place.
Figure 10
Figure 11
Figure 12
Figure 13
DETAILED INSTRUCTIONS RELATED TO USING RESQPOD ON AN ADVANCED
AIRWAY (E.G. ET TUBE):
Figure 14
Figure 15
FOLLOWING EACH USE OF THE RESQCPR SYSTEM
The ResQPOD is intended for single patient use only and should be discarded after use. Failure to
do so may cause cross contamination between patients. The ResQPUMP should be cleaned and
disinfected after every use.
RESQPUMP CLEANING
To clean the handle, wipe with damp cloth and mild detergent. The suction cup may be replaced
with a new suction cup, or cleaned. To clean the suction cup, wash it with a mild detergent and
rinse with tap water.
Never immerse the handle in water or autoclave to clean. Doing so may cause
permanent damage.
RESQPUMP CHEMICAL DISINFECTION
The handle and suction cup may be chemically disinfected after washing. Wipe the cup and
handle with a bleach solution (5% chlorine, minimum) or Cavicide
®
(follow manufacturer
instructions for wetting times). Wipe the handle with a dampened cloth to remove chemical
residue. Do NOT immerse the handle. The cup may be rinsed with water. Wipe with a clean
dry cloth and allow to air dry.
Hazards during disinfection. Always wear protective clothing during disinfection
of the ResQPUMP. Follow the handling instructions from the manufacturer of
the disinfectant.
NOTE: The cleaning procedure is sufficient after ‘normal’ soiling. If there are bodily fluids on the
ResQPUMP or if an infectious patient has been treated, the ResQPUMP should also be disinfected
as described above and the suction cup should be discarded and replaced.
RESQPUMP FUNCTION TESTING
Before placing the ResQPUMP into service and following each use, the following functional tests
should be performed:
1. Inspect the handle and suction cup for visible damage. Do not use the ResQPUMP if there is
obvious damage to the suction cup or handle. NOTE: Replacement suction cups are available
from the manufacturer.
2. Compress the ResQPUMP against a smooth hard surface with approximately 50 kg of force,
using the force gauge on the ResQPUMP as a guide. Observe for an increasing gauge
reading.
3. Pull up on the handle with approximately 10 to 15 kg of force, using the decompression
force gauge as a guide. Observe for a decreasing gauge reading and check for proper
suction. The gauge should move smoothly within the compression and decompression ranges.
4. Ensure that the force gauge reads zero (Figure 16) when no force is applied. If it does NOT
read zero, see instructions for force gauge readjustment below.
5. Assess the metronome’s battery level by pressing on the metronome button for more
than three seconds. If the battery is okay, first, a long high-note beep will be heard,
followed by three short beeps. If one long low-note beep is heard, or if no beep is heard,
the device should be replaced as well.
INDICATIONS FOR USE
The ResQCPR System is intended for use as
a CPR adjunct to improve the likelihood of
survival in adult patients with non-traumatic
cardiac arrest.
1 2
3 4 5
6
7 8 9
FORCE GAUGE CALIBRATION
If the zero reading of the force gauge (Figure 16) has drifted away from the zero line, the gauge
should be readjusted prior to further use as follows:
1. Remove the suction cup by pulling it from the stem of the handle.
2. Use a Phillips screwdriver to loosen the screw at the top of the connection stem (Figure 17)
with a firm turn. Remove the nylon stem and washer located inside the stem (Figure 18).
3. Insert a straight blade screwdriver (4 mm [1/8“] wide) in threaded hole at the end of the
spring/plunger assembly and catch the slot of the adjustment screw seated about 3 cm (1”)
down inside the brass plunger (Figure 18).
4. Loosen the screw. If there is excessive resistance, heat the screw slightly using a hairdryer to
soften the locking resin (Figure 19).
5. Loosen the screw and adjust it until the gauge is on the zero line (Figure 16). Compress the
spring a few times and check that the zero reading remains correct. Fine readjustment may
be needed. If the screw was heated, wait until it cools to room temperature before proceeding
to the next step.
6. Lock the screw by applying a drop of LOCTITE 242 locking fluid (or equivalent) to top edge
of screw. Use a toothpick to ensure that the fluid is applied directly to the entire top edge of
the screw. Wait ten minutes for the locking fluid to set.
7. Reassemble in reverse order. Place the washer into the nylon stem as shown in Figure 20.
Apply a drop of locking fluid to the tip of the thread near the end of the screw. Push the screw
up though the end of the stem and through the washer.
8. Finally, slip the spring/plunger on the handle down into the stem. Rotate the stem until the slot
in the stem aligns with the rib in the handle and slips all the way into the handle, then tighten
the screw.
9. Wait 24 hours before using the device to ensure that the locking resin obtains full strength.
During this time, the ResQPUMP should be hung by the strap or left resting on the handle
with the suction cup pointing up.
Figure 16
Figure 17 Figure 18
Figure 19
Figure 20
Decompression
Compression
30
0
kg
40
15
10
50
80/min
LIFT to 10 kgs
Use enough
force to
COMPRESS
to 2” (5 cm) depth
SUMMARY OF PRIMARY CLINICAL STUDY
Study Design and Methods
The ResQTRIAL was a prospective, multi-center, two-arm, randomized, controlled,
partially masked clinical study conducted under 21 C.F.R. §50.24,
Exemption from
Informed Consent under Emergency Circumstances,
and was funded by a grant from the
National Institutes of Health (NIH). Study oversight was conducted by an independent Clinical
Events Committee responsible for the review of all adverse events and inclusion/
exclusion adjudication and an independent Data Safety Monitoring Board to review
aggregate data to provide recommendations whether or not to continue subject
enrollment.
Rescuers provided CPR using the ResQCPR System at 80 compressions per minute (the S-CPR
group received compressions at the AHA-recommended rate of 100 compressions per minute).
Patients were followed for one year after cardiac arrest to determine if the ResQCPR System
improved survival rates after cardiac arrest. Neurological outcomes were assessed at the time of
hospital discharge, and then 30, 90 and 365 days after cardiac arrest.
The principal data elements that led to device approval were a post hoc analysis of
survival up to one year after cardiac arrest not incorporating the consideration of
neurological function. The primary safety and effectiveness endpoint defined in the
protocol was survival to hospital discharge with favorable neurologic function, defined as
a modified Rankin Scale score (MRS) of ≤ 3. The MRS assessment takes into consideration the
subject’s neurologic status both prior to and following cardiac arrest. However,
conclusions and inferences regarding the original prospective primary endpoint for the ResQTRIAL
(i.e., survival with good neurological outcome) cannot be drawn from the ResQTRIAL due to
interpretability issues related to the neurological component of that composite endpoint. The
hypothesis-based secondary safety endpoint was the overall rate of major adverse events through
hospital discharge. The hypothesis-based secondary effectiveness endpoint was long term
neurologic function assessed using the Cognitive Abilities Screening Instrument (CASI, Version
E-1.1) score at 90 and 365 days. CASI is measured on a scale of 0-100, with higher scores
signifying better outcomes.
All subjects in non-traumatic arrest determined by emergency medical services (EMS)
personnel to require CPR according to their local protocols were randomized and treated
in this study. The intention-to-treat (ITT) population was comprised of all subjects randomized to
S-CPR or CPR using the ResQCPR System who met the study enrollment criteria regardless of
the cause of the non-traumatic cardiac arrest. A subset of the ResQTRIAL ITT population was
comprised of patients who had a cardiac arrest of presumed cardiac etiology and who have the
potential to benefit from CPR. This subgroup was defined as the modified intention-to-treat (mITT)
primary analysis population. Baseline demographics and parameters were similar between study
groups as shown in Table 1.
Table1: ResQTRIAL Pivotal Phase Demographics and Baseline Characteristics
1
Parameter
S-CPR ResQCPR
ITT
(n=1201)
mITT
(n=813)
ITT
(n=1269)
mITT
(n=842)
Age, years (mean ± SD) 64.2 ± 17.2 66.8 ± 14.5 63.3 ± 17.8 67.0 ± 15.2
Male 752 (62.6) 539 (66.3) 803 (63.3) 559 (66.4)
Race:
White
Asian
Native Hawaiian/Pacific Islander
American Indian/Alaska Native
Black/African American
Unknown
960 (79.9)
39 (3.2)
4 (0.3)
18 (1.5)
152 (12.7)
28 (2.3)
660 (81.2)
31 (3.8)
3 (0.4)
9 (1.1)
94 (11.6)
16 (2.0)
1035 (81.6)
29 (2.3)
1 (0.1)
22 (1.7)
155 (12.2)
26 (2.1)
715 (84.9)
19 (2.3)
1 (0.1)
10 (1.2)
88 (10.5)
9 (1.1)
Ethnicity:
Hispanic/Latino
Not Hispanic/Latino
Unknown
22 (1.8)
1149 (95.7)
30 (2.5)
15 (1.8)
782 (96.2)
16 (2.0)
32 (2.5)
1207 (95.2)
29 (2.3)
19 (2.3)
811 (96.3)
12 (1.4)
Bystander witnessed arrest
EMS witnessed arrest
Unwitnessed arrest
Not available
517 (43.1)
146 (12.2)
536 (44.7)
2
383 (47.1)
76 (9.4)
353 (43.4)
1
546 (43.2)
144 (11.4)
575 (45.5)
4
400 (47.5)
80 (9.5)
361 (42.9)
1
Bystander CPR
Not available
489 (40.7)
1
350 (43.1)
1 (0.1)
532 (42.0)
2
358 (42.5)
0 (0.0)
Initial recorded cardiac rhythm:
Ventricular fibrillation/pulseless
ventricular tachycardia
Asystole
Pulseless electrical activity
Not available
294 (24.5)
597 (49.7)
293 (24.4)
17
247 (30.4)
379 (46.6)
180 (22.1)
7 (0.9)
335 (26.4)
633 (49.9)
284 (22.4)
16
292 (34.7)
376 (44.7)
171 (20.3)
3 (0.4)
911 call to EMS CPR start,
minutes
2
(mean ± SD)
6.7 ± 3.5 6.6 ± 3.4 6.7 ± 3.2 6.7 ± 3.2
911-to-first study device placed,
minutes (mean ± SD)
2
- - 7.1 ± 3.5 7.1 ± 3.5
Duration CPR, minutes (mean ± SD) 25.6 ± 13.0 27.60 ± 12.24 26.3 ± 12.3 28.10 ± 11.45
Pre-hospital ROSC
3
490 (40.8) 324 (39.9) 524 (41.3) 345 (41.0)
1
Numbers shown are subjects (%) unless otherwise indicated
2
Does not include subjects with EMS witnessed arrests
3
ROSC = Return of spontaneous circulation
Safety and Effectiveness Results
Survival
One of the major objectives of the ResQTRIAL was to determine the safety and effectiveness of the
ResQCPR treatment from the time of a return of spontaneous circulation (ROSC) to survival status
one year later; this is shown in Table 2. The results demonstrated that the likelihood of short and
longer-term survival was improved in the ResQCPR arm. At one year, there was a 34% increase
in the survival rate in subjects in the ITT population receiving CPR with the ResQCPR System
compared with S-CPR.
Table 2: Survival of Out-of-Hospital Cardiac Arrest Subjects Subjects from
ROSC to One Year
1
ITT mITT
S-CPR
(n=1201)
ResQCPR
(n=1269)
S-CPR
(n=813)
ResQCPR
(n=842)
ROSC during CPR before hospital
admission
490 (40.8) 524 (41.3) 324 (39.9) 345 (41.0)
Admitted to hospital 342 (28.5) 381 (30.0) 216 (26.6) 239 (28.4)
Survived to 24 hours
following arrest
Not available
277 (23.3)
12
310 (24.6)
11
176 (21.6)
9
199 (23.8)
6
Alive at hospital discharge
Not alive at hospital discharge
Not available
123 (10.3)
1072
6
150 (11.9)
1114
5
80 (9.9)
727
6
105 (12.5)
735
2
Alive at 30 days
Not alive at 30 days
Not available
98 (8.3)
1086
17
131 (10.4)
1123
15
65 (8.1)
738
10
96 (11.5)
741
5
Alive at 90 days
Not alive at 90 days
Not available
88 (7.5)
1089
24
116 (9.3)
1129
24
58 (7.3)
740
15
87 (10.4)
746
9
Alive at 1 year
Not alive at 1 year
Not available
68 (5.8)
1103
30
96 (7.8)
1137
36
48 (6.0)
746
19
74 (9.0)
748
20
1
Numbers shown are subjects (%) unless otherwise indicated.
Kaplan Meier survival analyses were performed in the subgroup of subjects who had a return
of spontaneous circulation (ROSC) for both the ITT and mITT populations (where the number of
subjects with ROSC is shown above in Table 1). The findings in these analyses are consistent with
the overall study results. The Kaplan Meier curves in Figure 21 show that the majority of subjects
with ROSC do not survive post-hospitalization out-of-hospital cardiac arrest. However, the Kaplan
Meier estimate of survival at one year was 30% higher in subjects in the ITT population receiving
CPR with the ResQCPR System compared with S-CPR (22.7% vs. 17.5%).
Figure 21: Kaplan Meier Analysis of Subjects with ROSC Following
Out-of-Hospital Cardiac Arrest
Importantly, there was no increase in the number of subjects with severe neurologic impairment
in the ResQCPR group, that is, the neurological outcome in patients who received CPR with the
ResQCPR System appeared to be no worse than the control (S-CPR). In the mITT, proportional
differences between the two treatment groups were observed to become larger over time.
Approximately 50% more subjects receiving CPR with the ResQCPR System were alive one year
after OHCA compared with those treated with S-CPR. However, this comparison was not
prospectively specified or adjusted for multiplicity.
Secondary Safety Endpoint
The analysis of safety was based on the randomized cohort of 2470 subjects in the ITT population
and 1655 subjects in the mITT subgroup available for the evaluation prior to hospital discharge.
The safety analysis included major adverse events that were reported during the pre-hospital
resuscitation effort and up to the point of hospital discharge, as applicable. There were no
differences in overall major adverse event rates between the study groups in the mITT population;
thus the secondary safety endpoint was met. Reported major adverse events by type are shown
in Table 3.
Event ITT mITT
S-CPR
(n= 1201)
ResQCPR
(n= 1269)
S-CPR
(n=813)
ResQCPR
(n=842)
Subjects with ≥1 major
adverse event through
hospital discharge (sec-
ondary safety endpoint
2
)
1129 (94.0) 1194 (94.1) 766 (94.2) 789 (93.7)
Death 1074 (89.4) 1115 (87.9) 729 (89.7) 735 (87.3)
Re-arrest 230 (19.2) 260 (20.5) 161 (19.8) 185 (22.0)
Stroke/cerebral bleeding 11 (0.9) 11 (0.9) 3 (0.4) 2 (0.2)
Internal organ injury 2 (0.2) 2 (0.2) 0 (0.0) 1 (0.1)
Hemothorax 3 (0.3) 3 (0.2) 1(0.1) 2 (0.2)
Bleeding requiring
intervention
8 (0.7) 17 (1.3) 3 (0.4) 7 (0.8)
Cardiac tamponade 4 (0.3) 5 (0.4) 3 (0.4) 2 (0.2)
Aspiration 20 (1.7) 16 (1.3) 7 (0.9) 8 (1.0)
Pneumothorax 11 (0.9) 13 (1.0) 7 (0.9) 10 (1.2)
Seizure 19 (1.6) 23 (1.8) 13 (1.6) 11 (1.3)
Rib/Sternal fracture 23 (1.9) 18 (1.4) 14 (1.7) 11 (1.3)
Pulmonary edema
3
96 (8.0) 143 (11.3) 62 (7.6) 94 (11.2)
1
Numbers shown are subjects with at least one report of the listed adverse event types. If multiple events of same type were
reported, the event is only counted once per subject. Reports of deaths, re-arrest, seizure, and pulmonary edema in the field
(e.g., pre-hospital) are also shown. All other adverse event types were assessed based on review of medical records for
subjects transported to a hospital. There were no Major Adverse Events associated with device malfunctions, defects, or
failures.
2
Secondary safety endpoint: The rate of major adverse events in the ResQCPR group (mITT) was found to be non-inferior to
that in S-CPR group (p < 0.0001) within a non-inferiority margin of 5%.
3
Data shown includes combined pre-hospital and in-hospital reports of pulmonary edema. Pulmonary edema was defined
as any of the following: Pre-hospital reports of advanced airway filled with fluid ≥2 times; blood, mucous, fluid or other
secretions in the airway; reports of pulmonary edema or pleural/pulmonary effusion on post-mortem examinations; and, for
subjects transported to a hospital, in-hospital reports of pulmonary edema or pleural/pulmonary effusion confirmed on x-ray
or CT scan. Pre-hospital pulmonary edema was reported in 22 patients (2.7%) in the S-CPR group, and in 30 patients (3.6%)
in the ResQCPR group (mITT).
The only difference in adverse events between the two groups was the observation that more
patients receiving CPR with the ResQCPR System had pulmonary edema. A post hoc analysis
appeared to demonstrate that the presence of pulmonary edema did not adversely affect
effectiveness as measured by survival.
Secondary CASI Effectiveness Endpoint
The pre-specified secondary effectiveness endpoint was an evaluation of long-term neurological
function using Mean Cognitive Abilities Screening Instrument (CASI) scores at 90 and 365 days.
The study was not able to demonstrate an improvement in neurologic function in the ResQCPR arm
based upon CASI scores (as was hypothesized); however, CASI scores were not significantly
different among survivors who were discharged from the hospital. The mean scores included
subjects who died after hospital discharge, with a CASI score equal to 0 assigned to those who
died. More than 85% of the one-year survivors in both study arms completed the one-year CASI
assessment and the mean CASI scores for these subjects were 93.7 ± 11.8 (n=30) in the S-CPR
arm and 94.7 ± 4.4 (n=41) in the ResQCPR arm for the mITT population, consistent with full or
nearly full recovery in both groups; ITT scores were 91.9 ± 13.5 (n=43) in the S-CPR arm and
92.3 ± 12.3 (n=49) in the ResQCPR arm.. There were only three patients with CASI scores <70,
a score consistent with poor neurological function, in both groups. There is limitation in interpreting
the comparison of these CASI results between groups, since the comparison is not based on all
randomized patients but rather is conditional on the survival of subjects at 90 days or 1 year.
Subjects with a Drug/Medication Overdose
A post-hoc analysis of subjects with a presumed medication or drug overdose, as determined by
CEC adjudication, suggested that CPR using the ResQCPR System in this patient population may
have resulted in unfavorable clinical results for drug/medication overdose patients as compared to
both 1) S-CPR for drug/medication overdose patients, and 2) CPR utilizing the ResQCPR System
for non-traumatic arrest patients not having drug/medication overdose as the arrest etiology.
Among S-CPR and ResQCPR subjects with drug/medication overdose arrest etiologies, 20% of
S-CPR (13/65) and 14% of ResQCPR (14/97) subjects survived to hospital discharge.
Overall Conclusions
The results of the pivotal trial demonstrate that the ResQCPR System increased the likelihood of
survival after non-traumatic out-of-hospital cardiac arrest when compared with manual S-CPR, the
current standard of care for treatment of out-of-hospital cardiac arrest in the United States today.
One year survival rates were relatively 34% higher when CPR was performed with the ResQCPR
System compared with S-CPR for all subjects in the ITT population (7.8% vs. 5.8%), and relatively
49% higher for those in the mITT population (9.0% vs. 6.0%). These principal data elements that
led to device approval by FDA, and are accordingly represented in the labeling and indications
for use for the ResQCPR System, were a post hoc analysis of survival not incorporating the
consideration of neurological function. One year after OHCA, more than 95% of surviving
subjects in both treatment groups had excellent neurological function, as determined by cognitive,
functional, and quality of life testing. In cardiac arrest of etiology known to be drug/medication
overdose, the favorable results with use of the ResQCPR System may not be present.
RESQPOD ITD 16 TECHNICAL SPECIFICATIONS
Operating Specifications
Safety check valve threshold –16 cmH
2
O
Expiratory airway impedance <5 cmH
2
O
Timing assist lights flash rate 10/min
Shelf Life
Four years
Temperature Range
Operation -18º to 50º C (0º to 122º F)
Storage -40 to 60º C (-40º to 140º F)
Dimensions
Height 8.2 cm
Diameter 5.3 cm
Circumference 16.6 cm
Patient side connection 15 mm ID/22 mm OD
Ventilation side connection 22 mm ID
Dead space 41 ml
Weight 62 gm
Materials
Exterior housing and interior molded components Polycarbonate
Diaphragm and safety check valve gasket Silicone
Safety check valve spring Nickel plated stainless steel
Battery 3 V disposable lithium ion coin cell
ResQPOD and ResQPUMP are registered trademarks of Advanced Circulatory. These products and
their use are protected by one or more of the following patents: USA – 5,645,522; 6,155,257;
6,224,562; 6,234,985; 6,312,399; 6,425,393; 6,463,327; 6,587,726; 8,151,790.
Foreign – CNZL96193712.2; EP0898485 (France, Germany, Italy, Sweden, United Kingdom).
Other USA and country patents pending.
RESQPUMP ACD-CPR DEVICE TECHNICAL SPECIFICATIONS
Operating Specifications
Force gauge compression range 0 - 50 kgs ± 15%
Force gauge decompression range 0 - 15 kgs ± 15%
Metronome Function
Signal pitches 768 Hz (low) and 3070 Hz (high)
Sound level ≥65 dB at distance of 0.5 m for sound source
Rate 80/min
Temperature Range
Operation -18º to 50º C (0º to 122º F)
Storage -40 to 60º C (-40º to 140º F)
Dimensions
Suction cup 13.5 cm OD
Height 17.0 cm
Weight 0.58 kg (1.28 lb)
Materials
Suction cup and cushion pad Silicone
Handle and support ring Polyamide (nylon), glass fiber reinforced
Connection stem Acetal polyoxymethylene
Support ring Thermoplastic polyester elastomer
Metal parts Stainless steel and brass
Battery 3.6 V primary lithium-thionyl chloride
ACCESSORIES AND REPLACEMENT COMPONENTS AVAILABLE
FOR THE RESQCPR SYSTEM
Reorder # Description
12-0825-000 ResQCPR System (one ResQPUMP; two ResQPODs)
12-0822-000 ResQPOD ITD 16 (single device)
12-0823-000 ResQPUMP ACD-CPR Device (single device)
12-0586-000 Suction Cup for ACD-CPR Device (replacement suction
cup with support ring and compression cushion)
12-0935-000 ResQCPR Carrying Case (holds one ResQPUMP and two ResQPODs)
Table 3: ResQTRIAL (Out-of-Hospital Cardiac Arrest) Subjects with Major Adverse
Events Through Hospital Discharge
1
LIMITED WARRANTY
Subject to the terms, conditions and limitations contained herein, Advanced Circulatory warrants only to the
ultimate user of the product that Advanced Circulatory’s products will not fail to operate in accordance with their
specifications due to defects in material or workmanship during the time period listed below. The foregoing period
is sometimes referred to as the “original warranty period.” The foregoing limited warranty does not apply to any
part, portion, or component of any product which is manufactured by a third-party (“Third-Party Component”). The
time period for the warranty begins on the date of delivery of the product to the first purchaser. ResQPOD: Period
ending on the earlier of the date of first use or the expiration date on the package for the product provided by
Advanced Circulatory. ResQPUMP: 12 months
THE LIMITED WARRANTY SET FORTH IN THE FOREGOING PARAGRAPH, IS THE SOLE AND EXCLUSIVE
WARRANTY WITH RESPECT TO ADVANCED CIRCULATORY’S PRODUCTS. ADVANCED CIRCULATORY
MAKES NO OTHER EXPRESS WARRANTY OF ANY KIND OR NATURE AS TO THE PRODUCTS OR THEIR
PERFORMANCE EXCEPT FOR THOSE LIMITED WARRANTIES EXPRESSLY SET FORTH IN THE FOREGOING
PARAGRAPH AND EXCEPT THEREFORE, SPECIFICALLY DISCLAIMS ANY AND ALL REPRESENTATIONS OR
WARRANTIES OF ANY KIND OR NATURE CONCERNING THE PRODUCTS, INCLUDING, BUT NOT LIMITED
TO, ANY REPRESENTATION OR WARRANTY THAT THE PRODUCTS COMPLY WITH ANY LAW, OR THAT ANY
PARTICULAR RESULT WILL BE OBTAINED BY USING THE PRODUCTS. ADVANCED CIRCULATORY MAKES NO
WARRANTIES WITH RESPECT TO ANY THIRD PARTY COMPONENT AND ADVANCED CIRCULATORY
SPECIFICALLY SELLS SUCH THIRD-PARTY COMPONENTS “AS IS” WITHOUT ANY WARRANTY. FURTHER,
ADVANCED CIRCULATORY MAKES NO IMPLIED WARRANTY OF ANY KIND OR NATURE WITH RESPECT
TO ITS PRODUCTS OR ANY THIRD-PARTY COMPONENT AND SPECIFICALLY DISCLAIMERS ANY AND
ALL IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, ANY AND ALL IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR COMPLIANCE WITH
ANY FEDERAL, STATE OR LOCAL LAW, RULE OR REGULATION. IN ADDITION, ADVANCED CIRCULATORY
EXPRESSLY DISCLAIMS TO THE FULLEST EXTENT ALLOWED BY LAW, RULE OR REGULATION ANY WARRANTY
PROVIDED UNDER ANY LAW.
The limited warranties set forth above shall be null and void if (a) any alterations or modifications are made to
a product, (b) a product is not maintained in strict compliance with the maintenance requirements set forth in the
maintenance manual for such product or otherwise provided by Advanced Circulatory, (c) any repairs are made
to a product which are not authorized by Advanced Circulatory in writing, (d) any failure of a product to comply
with the above limited warranty is not reported to Advanced Circulatory in writing within thirty (30) days of the
date such failure first occurs, (e) a product is operated after the failure of any warranty first occurs, (f) a product is
used for any purpose other than for the purpose for which it was manufactured, (g) a product is not operated in
strict compliance with the terms and conditions set forth in any operating manual, notice or other statement
accompanying the product, (h) a product is abused or damaged, (i) purchaser fails to deliver the product to
Advanced Circulatory for inspection and testing if requested by Advanced Circulatory or purchaser disposes of
the product or any part or component on or before the thirtieth (30th) day after sending a written claim under the
warranty to Advanced Circulatory, (j) such failure of the limited warranty results from a failure of any third party
component, or (k) a product is not stored or handled as directed in writing by Advanced Circulatory.
The sole and exclusive remedy for any failure of any product to comply with the limited warranty set forth above
or any other warranty imposed upon Advanced Circulatory by Law, if any, shall, at the election of Advanced
Circulatory, in its sole discretion, be either (a) the repair or replacement of the product or component which failed
to comply with such warranty or (b) the refund of the purchase price of the product. Except as provided below,
any repair or replacement shall carry the same warranty as the original product but only for the remainder of the
original warranty period. Purchaser’s exclusive remedy with respect to any claim arising out of or as a result of
third-party component shall be against the third-party manufacturer.
Any and all claims under the above limited warranty shall be made to Advanced Circulatory only in writing and
not later than thirty (30) days after the date the product first fails to comply with the above limited warranty but in
no event later than the expiration of the original warranty period with respect to which the claim is being made.
Any claim under the above limited warranty made after such period for making a claim shall be null and void.
After receiving written notice of the warranty claim, Advanced Circulatory shall determine whether to (a) repair
or replace the product or part or (b) refund the purchase price of the product. Advanced Circulatory may require
purchaser to return any Product or component thereof which purchaser claims to be defective to Advanced
Circulatory at purchaser’s cost for inspection as a condition to any claim under the above limited warranty.
No product or part may be returned to Advanced Circulatory without Advanced Circulatory’s prior written
authorization. If a product which is returned is determined by Advanced Circulatory in its sole discretion not to
have failed to comply with the limited warranty, purchaser shall pay costs of removal, repair and/or replacement
for such product. If a product which is returned is determined by Advanced Circulatory n its sole discretion to have
failed to comply with the limited warranty, Advanced Circulatory shall pay for all repair and/or replacement costs
for such product (or refund the purchase price if so elected by Advanced Circulatory) and Advanced Circulatory
shall reimburse purchaser for the reasonable costs of shipping the product or component to purchaser.
17-0829-000, 08
Manufactured by:
Advanced Circulatory
1905 County Road C West, Roseville, MN
55113 USA
Telephone: 651-403-5600
Customer service: 1-877-737-7763
Email: info@AdvancedCirculatory.com
Website: AdvancedCirculatory.com
10
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